Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients older than 18 years of age,
- •ASA classification class I and II,
- •Patients assigned for Whipple procedure.
排除标准
- •Preoperative renal failure,
- •Severe liver dysfunction (Child-Turcotte-Pugh grade C),
- •Hyponatremia (Na+ <132mmol/l),
- •Severe valvular heart disease,
- •Heart failure,
- •Symptomatic coronary heart disease,
- •Bradycardic arrhythmia (heart rate < 60/min),
- •Peripheral artery occlusive disease (clinical stadium II-IV),
- •Uncontrolled arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment),
- •Pregnancy.
研究组 & 干预措施
Terlipresssin
Terlipressin was started at the beginning of surgery, just after exposure of the portal vein and getting a basal portal pressure reading, as an initial bolus dose of 1 mg over 30 minutes (1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.
干预措施: Terlipressin (Drug)
Control
patients received the same volume of normal saline for the same duration (50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours)
干预措施: normal saline (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: intaoperative periods
Amount of intraoperative blood loss in ml
次要结局
- portal pressure changes(intaoperative periods)
- ICU stay(postoperative periods)
- Patients needing blood transfusion(intaoperative periods)
- Red blood cell units transfused(intaoperative periods)
研究者
Magdy Mohammed Mahdy Sayed
Assiut-Egypt
Assiut University